Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06679907
NA

Medico-economic Evaluation of the Creation of Arteriovenous Access for Hemodialysis Between Surgical Technique and Endovascular Technique in Patients with End-stage Renal Disease

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

This multicenter 1 :1 randomized controlled trial aims at comparing the cost-effectiveness of endovascular arteriovenous fistula (AVF) creation using Ellipsys® and WaveLinQ® devices with traditional surgical AVF creation for hemodialysis. The primary endpoint is the cost-utility ratio (cost per QALY gained), with an anticipated sample size of 252 patients. This study will provide critical insights into the viability and cost-effectiveness of endovascular techniques, potentially shaping future standards of care in hemodialysis access.

Official title: Cost-effectiveness Study Comparing Endovascular and Surgical Arteriovenous Fistula Creation for Haemodialysis in Patients with End-stage Renal Failure

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2025-01-15

Completion Date

2030-01-15

Last Updated

2024-11-14

Healthy Volunteers

No

Interventions

DEVICE

WaveLinQ® device

The WaveLinQ® system employs a dual catheter technique to establish communication between deep arteries and veins, typically using a ulnar or radial artery and vein. This procedure necessitates fluoroscopic guidance to position the catheters correctly, a control angiogram, and potential embolization to enhance blood flow.

DEVICE

Ellipsys® device

The Ellipsys® system enables the entire AVF creation process to be conducted under ultrasound guidance without the need for fluoroscopy or contrast media. It uses a single needle to puncture the superficial vein, the perforator and the artery and potential balloon angioplasty to enhance blood flow.

DEVICE

No device

Surgical AVF creation will involve a direct approach to the proximal radial, ulnar, or brachial artery to create a 4-6 mm longitudinal arteriotomy. An oblique incision will be made at the elbow crease. The cephalic, basilic, or perforating vein may be used for the side-to-end anastomosis. If a transposition is required due to adiposity, it will be performed either during the same procedure or at a later time through tunneling or lipectomy.

Locations (11)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

Polyclinique Bordeaux Nord Aquitaine - Centre Aquitain des pathologies vasculaire

Bordeaux, France

AP-HP Centre Hospitalier Universitaire d'Ambroise Paré

Boulogne-Billancourt, France

Clinique du parc

Castelnau-le-Lez, France

Centre Hospitalier Universitaire de Dijon - Hôpital le Bocage

Dijon, France

Centre Hospitalier Mutualiste de Grenoble

Grenoble, France

Hôpital privé Jean Mermoz

Lyon, France

Centre Hospitalier St Joseph - St Luc

Lyon, France

Centre Hospitalier Universitaire de Nice - Hôpital Pasteur 1

Nice, France

Groupe Hospitalier Paris St Joseph - Centre Hospitalier Chartres

Paris, France

Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec

Saint-Herblain, France